The Pediatric Device Center is dedicated to the advancement of pediatric innovation within the healthcare and device industry. Our collaborative approach allows us to provide expertise, cost-effective services, and a wide variety of resources with the help of volunteers and members from around the world. We also partner with healthcare providers, FDA, non-profit organizations, institutions, consortiums, and other industry experts in order to help bring pediatric innovation to life.

1. THINK big &
SMALL
InnovativeApproach to Pediatric Device Development
Angel Adams

2. Bridgin
g
the Gap
Lack of Pediatric Innovation
 Development Costs
 Lack of Funding and
Investment
 Costs and Risks associated
with ClinicalTrials
 Limited Research and Data
 Growth Rate
 FDA Regulations
 Limited Distribution
Channels
Pediatric Needs
 Medical Devices
 Pharmaceuticals
 HealthIT
 Improved Patient Care
 Access to Resources
 Research & Data
 Customized Equipment

3. Pediatric
Device
Innovation
Process
 Unmet Needs
 Market Assessment
 Concepts & Ideas
 Device Design
 Institution vs. Industry
 Management
 Funding & Investors
 Development Process
 Regulatory
 Pre-Clinical & Clinical
 Commercialization
 Distribution

4. Pediatric
Needs &
Market
Assessment
Needs &
Market
• How do you find pediatric needs?
• Who do you contact within the pediatric industry?
• Where do you find pediatric market data and
information?
• Can you use adult research and data for pediatrics?
• What is the size of the pediatric market?
Current
Issues
• Limited research and data available within pediatrics.
• Contact physicians directly through social media
channels, referrals, and other limited connections.
• Institutions are not keen on these methods unless
there is a consultation fee.
• Many healthcare providers need to go through an
approval process in order to give expertise and advice
unless they state they are volunteering.

5. Scenarios:
PediatricUnmet
Needs & Market
Assessment
EXAMPLE: Medical Device
Innovation Students
This program provides students
with an overall view of the
medical device industry, with an
emphasis on unmet needs.
Problem:There is not an easy
way to discover unmet needs
especially within pediatrics
because the needs are
widespread.
EXAMPLE: FDA Unmet Needs
Assessment
The FDA is rolling out an unmet
needs assessment in 2015, but it is
not specifically designed for
pediatrics.
Problem: If you look at the unmet
needs nationally and globally, the
pediatric need is not significant
enough compared to the needs of
the adult market. Even if they
developed a pediatric unmet needs
assessment, we would still have
the same obstacles.

6. Pediatric
Device
Concept &
Device
Design
Concept &
Design
• Is this a new concept or modification of an existing
adult device?
• Are you currently make-shifting an adult device to fit
pediatrics?
• What risks are associated with this device?
• Where do you go with your idea or prototype?
• Where do you find pediatric resources and expertise?
Current
Issues
• Healthcare providers are unable to take ideas
outside of the institution without approvals and
signed agreements.
• Funding is limited within institutions and
industry, resulting in limited options for
pediatrics.

7. Scenarios:
Pediatric
Device
Concept &
Device Design
EXAMPLE: Devicix
Devicix specializes in product
development: Receive calls
from physicians asking for
resources and help to develop
their concept.
Problem: Devicix has limited
options available for them.
EXAMPLE: “Pediatric”
Device Design
A device company in
Minnesota developed a device
that secures the catheter in
place.They sell and promote
the pediatric version of this
device because of it’s size.
Problem: The smaller version
of the device has never been
tested on children.The cost
compared to the market is too
high, so the company will not
clinically test it in children.

8. Industry vs.
Institution
related to
Pediatrics
Industry
Product
Development
Investment
Distribution
Channels
Institution
Clinical
Healthcare
Providers
Needs
Funding
Students
Research & Data

9. Scenarios:
Industry vs.
Institution
related to
Pediatrics
EXAMPLE: Prevention of an
Asthma Attack in Children
A medical student developed a
device around a unique sensor,
owned by a university, which
detected inflammation in the
throat before the onset of an
asthma attack.
Problem: The university
owned the main sensor
technology for his device.The
release of this technology will
be challenging, making it hard
to secure investors.
EXAMPLE: Pediatric Device
Consortiums
There are seven federally funded
pediatric consortiums in the United
States, and the federal
government has allocated $19
million dollars to them since 2009.
Since then, they have funded over
330 projects and only two have
made it to market.
Problem: Devices are developed
within the institution and IP can
prevent partnerships with the
industry. Guidelines on how to
spend grants.

10. Pediatric
Device
Company
Management
Team
Offers & Board
of Directors
• How did you appoint officers?
• What experience and skills do you look for?
• How do you choose your Board of Directors?
• How much diversity do you have on your board?
• What is the motivation behind becoming a board member?
• How many of your board members are on other boards?
Advisory
Board
• Do you have a volunteer advisory board?Why or why not?
• What is the motivation to join an advisory board?
Current
Issues
• The founder of the technology appoints himself as CEO.
• The most important step in the process and often the
reason a great technology will fail.
• Stakeholders normally appoint Board Members with
limited experience within pediatrics.

11. Scenario:
Pediatric
Device
Start-Up
Company
Founder and Officers
 Founder  CEO
 Appoint Officers and Management
with no pediatric industry
experience
 Limited pediatric
commercialization experience and
expertise
 Costs of development are higher
because of the lack of resources
and expertise within pediatrics
 Don’t look at the technology
objectively
 The long term plan in unclear
 Market assessment is inaccurate
 Believe they will commercial alone
Investors & Board of Directors
 Investors invest in technology
and management
 Investors appoint Board of
Directors without
understanding the pediatric
market, but the founders often
don’t understand the pediatric
market either
 Pressure on the device
company for a return, which
can lead to mistakes during
development
Advisory Board
• Missing in most start-ups
• Benefits are significantly
greater
• Motivation to help get a
pediatric device to market

12. Investors,
Grants, and
Crowd-Funding
within
pediatrics
Investors
• What is your approach to investors? Do you tailor your
approach?
• What amount are you asking for?Why?
• Why have you been told no or yes by an investor?
• How do you find potential investors?
• Do you have a long-term plan?
Grants &
Funding
• Do you know which grant options are available?
• How do you apply for grants?
• What limitations are associated with federal funding?
• What are the guidelines for spending that money?
• How much did you spend crowd-funding campaigns?
• How much did you raise?
• Which media outlets did you use?
Current
Issues
• Approaching investors without a good plan and
pediatric expertise within management
• Pediatric device development expertise doesn’t really
exist
• Asking for an unrealistic and unnecessary amount of
money without a thorough market assessment

13. Scenarios:
Investors,
Grants, and
Crowd-Funding
within
pediatrics
EXAMPLE: Detecting Sleep
Apnea in Children
LicensedTechnology:Antibody
that attached itself to protein
in urine.
 Clinical Study: Showed it was
96% accurate in children to
detect sleep apnea.
 Asking for $2 million for the
development of the antibody
and clinical trials.
Problems: Turned down by
investors because the market
was too small.
 Using one clinical site and
one company to develop the
antibody.
 No innovative approaches
taken
EXAMPLE: Lazy Eye
DetectionTechnology
Developed a technology that
detected lazy eye in young
children.
 Received grant award from
consortium.
Problems: Turned down by
investors because they didn’t
have the right expertise on
their team.
 Didn’t have a plan for
distribution or pre-market
study.
 Unrealistic cost for the
device.
 Limited access to resources.

14. Development
Process and
Resources
within
Pediatrics
Resources &
Processes
• What research and data is available? From
where?
• Are you utilizing outside resources during
development?
• How much do you spend during development?
Current
Issues
• Access to research and data is limited.
• Resources are hard to find.
• The industry and intuitions don’t partner
enough.
• Companies don’t utilize outside resources
enough.
• Not enough out-of-the-box thinking.

15. Scenarios:
Development
Process &
Resources with
Pediatrics
EXAMPLE: Pediatric Injector
Prototyped an injector that could fit in your
wallet or on the back of a phone.The cost
for this device was less than the cost the
competitors.They received funding for
initial development for adults.
 Problem: Pediatric market was included
to attract investors.
 Not including the pediatric market or
increasing the costs to modify their device
for pediatrics would decrease investment
options.
 The amount of epinephrine administered
is .3 mg for >66 lbs. and .15 mg for < 66
lbs.
 The design was not conducive for
pediatrics unless administered by an
adult. Children begin to carry their
injectors around the age of 12.
 Market research showed that current
options for children often hit the bone
when administered.To change the needle
size, the development cost would
increase.
 The cost was roughly $50 dollars less, but
injectors are used infrequently.
EXAMPLE: Pegasus
Therapeutics
Developing a bioresorbable
flow diverter for children with
atrial aneurysms.
Problem: This is a Class III
device and the development
process will require a
significant amount of outside
resources. Start-ups have
limited access to resources and
research.

16. Regulatory
within
Pediatrics
Pathways &
FDA
• Which regulatory pathway should a pediatric
device company take?
• What relationship do you have with the FDA?
• How much preparation have you done before
approaching the FDA?
Current
Issues
• The FDA does not recognize research and data from
other countries.
• The industry doesn’t always have the right approach to
the FDA.
• The problems within the FDA extend far beyond
working with the individual departments.
• The risk of using make-shifting adult devices is greater.

17. Scenario
s:
Regulatory
within
Pediatrics
EXAMPLE: Pediatric ENT
Device
Pediatric ENT device that
prevents children from
undergoing general anesthesia
during the procedure of placing
tubes in the ears.
 After 75 successful
procedures, the FDA asked
for the device to prove it’s
success with each topical
used.
Problem: Unnecessary costs
and time for the device
company.
EXAMPLE: Cardiovascular
Device Company
A cardiovascular company in
CA modified their adult device
to fit children.The CEO has
spent a lot of time talking to
the FDA about the process to
get it clinically proven in
children.
Problem:The FDA can’t give
them a good reason to do it.

18. Pre-Clinical &
Clinical within
Pediatrics
Clinical
Resources
• Are you using outside pre-clinical resources during
every stage of your development?
• What clinical research have you found in other
countries?
Current
Issues
• The FDA doesn’t recognize clinical studies done in
other countries.
• Parents do not want their children in clinical trials.
• The cost for clinical trial within pediatrics is high.

19. Scenarios:
Pre-Clinical &
Clinical within
Pediatrics
EXAMPLE: American Pre-
Clinical Services
APS is a pre-clinical company
in MN that has a special
interest in pediatrics.
Problem: A majority of the
pediatric devices that come in
for pre-clinical services are sent
back for re-design because
they are not small enough to
navigate within the body.
EXAMPLE: University
Pediatric ClinicalTrial
The university is conducting
the largest pediatric clinical
trial to test the number of
pedicle screws needed for a
child with scoliosis.The lower
the number, the lower the cost.
Problem: They need help with
the dissemination of their
research and access to more
resources.

20. Distribution and
Strategy within
Pediatrics
Distribution &
Exit Strategies
• How do you distribute pediatric devices to all of the
small markets?
• Can you commercialize your pediatric device on your
own?
• Do you plan on selling or licensing your device?
Current
Issues
• The market for pediatric devices does exist, but you
would have to hit every small market around the world.
• Large companies take the credit for their pediatric
devices.
• Insurance reimbursement for pediatric devices.

21. What does a
pediatric device
company need
to innovate and
succeed?
They don’t
always know
what they need.
Resources
Pediatric
Device
Expertise
Management
Innovative
Solutions to
Pediatric
Innovation

22. Pediatri
c
Device
Center
The Pediatric Device Center is dedicated to the advancement of
pediatric innovation within the healthcare and device industry. Our
collaborative approach allows us to provide expertise, cost-effective
services, and a wide variety of resources with the help of volunteers
and members from around the world.We also partner with
healthcare providers, FDA, non-profit organizations, institutions,
consortiums, and other industry experts in order to help bring
pediatric innovation to life.

23. Global
Collaborati
on is Key
Pediatric
Device
Companies
Adult Device
Companies
Contract
Manufacturers
Discounted
Services
Pre-Clinical &
Clinical
Services
FDA Investors Government
IT Services Volunteers
Healthcare
Providers
Contract
Services
Companies
Institutions Policy
Insurance
Companies
If we had a representative from each of these categories
in this conference room, could we find a solution?

24. Global
Network &
Pediatric
Innovation
Portal
Pediatric Product Database
• Healthcare providers will have access to a pediatric product database, which includes
devices, pharmaceuticals, software systems, and other pediatrics products
• Ability to order products directly from the companies and distributors
Pediatric Research
• Consolidation of pediatric research pertaining to devices and pharmaceuticals
• Access to a research database for providers and device companies
• Access to current global pediatric clinical trials
Pediatric Needs Assessment
• Allow for healthcare providers and others to post pediatric needs
• Ability to connect live via the portal to discuss needs with industry professionals
• Pediatric Needs Assessment
• Pediatric Provider Database
• Access to a searchable database for the industry to connect with healthcare providers in
order to gain feedback and expertise
Discounted Member Services
• Pediatric device companies will be able to search for services offered by our members
• Access to volunteers and other individuals willing to share and provide their expertise
Grant Funding and Investors
• Access to a searchable database for grant funding given by consortiums and other entities
• Start-ups will have access to available investors and venture capitalists
• Access to resources to help start-ups prepare for investor presentations
• Investors will have the ability to search for start-up device companies
Pediatric Device Center Updates
• Post updates on our progress
• Post news from our members

25. Questions?